title: The systematic production of cells for cell therapies.
abstract: Stem cells have emerged as the starting material of choice for bioprocesses to produce cells and tissues to treat degenerative, genetic, and immunological disease. Translating the biological properties and potential of stem cells into therapies will require overcoming significant cell-manufacturing and regulatory challenges. Bioprocess engineering fundamentals, including bioreactor design and process control, need to be combined with cellular systems biology principles to guide the development of next-generation technologies capable of producing cell-based products in a safe, robust, and cost-effective manner. The step-wise implementation of these bioengineering strategies will enhance cell therapy product quality and safety, expediting clinical development.
authors.affiliation: Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, ON M5S 3E1, Canada.
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Kirouac
authors.forename: Peter W
authors.initials: PW
authors.lastname: Zandstra
mesh_terms: D001672:Biocompatible Materials / Q000009:adverse effects / Q000592:standards; D054316:Biomarkers, Pharmacological / Q000378:metabolism*; D019149:Bioreactors / Q000600:supply & distribution; D002454:Cell Differentiation; D064987:Cell- and Tissue-Based Therapy / Q000191:economics / Q000295:instrumentation / Q000379:methods; D003363:Cost Control; D004353:Drug Evaluation, Preclinical; D053595:Embryonic Stem Cells / Q000166:cytology / Q000378:metabolism / Q000637:transplantation; D020869:Gene Expression Profiling; D017408:Guidelines as Topic / Q000592:standards; D006801:Humans; D020411:Oligonucleotide Array Sequence Analysis; D011786:Quality Control; D021281:Quantitative Structure-Activity Relationship; D033581:Stem Cell Transplantation / Q000191:economics / Q000592:standards
chemical_list: D001672:Biocompatible Materials; D054316:Biomarkers, Pharmacological